A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma

Sponsor
Immodulon Therapeutics Ltd
Study ID
NCT03711188
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.
  • Ipilimumab — DRUG
    Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.
  • IMM-101 — DRUG
    A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

Study Details

The purpose of this study is to assess the safety and efficacy of the combination of IMM-101 with nivolumab.

Key Dates

Start date
Oct 4, 2018
Status verified
Nov 2023
Primary completion
Dec 2, 2021
Completion
Dec 2, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IMM-101 (and nivolumab or ipilimumab)
    Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab.

Primary Outcome Measure

Safety and Tolerability of the Combination of IMM-101 + Nivolumab [ Time Frame: From the point of Informed Consent until end of the study assessment (up to 84 weeks) or until withdrawal from the study. ]

Related Studies